Our client, a leading pharmaceutical company that operates globally and employs over 45,000 people, is seeking a PV Manager (Operations) to join their team in Berkshire, UK. The company specialise in a variety of therapy areas including respiratory, oncology and immunology.
- Lead/manage Pharmacovigilance (PV) Staff and Operations
- Create, implement and maintain local PV policies and procedures and support the Head of Pharmacovigilance (Local Pharmacovigilance Manager) with establishing and maintaining a local PV system in compliance with internal procedures and external requirements (e.g. local and international regulation).
- Ensure appropriate single case management including receipt of domestic cases and distribution to global data entry, response to queries (incl. reminders) including tracking and reporting of all received cases to HAs according to local legal requirements.
- Provide coaching, encourage and identify opportunities for continuous improvement and selfdevelopment to optimise their perfomance.
- Deputise for the Local Pharmacovigilance Manager as required and report any relevant changes to the product portfolio, licensing activities, clinical trial and post marketing activities, local processes, local PV regulations, audits and inspections activities and Health Authority requests.
- Ensure adequate Safety training of all company staff to ensure that safety data collection from any source and safety reporting to concerned stakeholders is performed in compliance with internal procedures and according to current international regulations.
- Continuously identify compliance issues and implement CAPAs.
- Participate in PV audits and PV inspections and implement post inspection CAPAs.
- Perform Safety Surveillance tasks, signal detection for local products and review safety sections of local labelling.
- Coordinate safety issues with local management, the regional PV head and GPV
- Review, assess and track accordingly local trial and non-trial activities and Create and maintain local PV agreements.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on +44 203 7520 313 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.